比利时阿普米司特治疗银屑病的真实疗效：观察性 OTELO 研究结果。
Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study.
机构信息
Department of Dermatology, University Hospitals Saint-Luc, Av. Hippocrate 10, 1200, Brussels, Belgium.
Department of Dermatology, Ghent University Hospital, Ghent, Belgium.
出版信息
Adv Ther. 2022 Feb;39(2):1068-1080. doi: 10.1007/s12325-021-01981-7. Epub 2022 Jan 3.
INTRODUCTION
Apremilast is approved for the treatment of psoriasis and psoriatic arthritis. However, data on the efficacy and safety of apremilast in clinical practice are limited. We assessed the real-world use and effectiveness of apremilast in patients with moderate to severe plaque psoriasis visiting dermatologist practices in Belgium, from the perspectives of the patient and the physician.
METHODS
This prospective observational study enrolled adults aged 18 years or more initiating apremilast between 6 April 2017 and 30 June 2018, per Belgian reimbursement criteria. Primary outcome was the Patient Benefit Index for Skin Diseases (PBI-S). Secondary outcomes included the Patient Global Assessment (PtGA), Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and body surface area (BSA). Patients were followed up for up to 18 months.
RESULTS
Overall, 122 enrolled patients received at least one dose of apremilast, of which 89 received treatment for more than 150 days and were included in the reference population. Treatment goals most frequently identified (at least 70% of patients) as "very important" in the PBI-S were related to physical impairments. After 6 months of apremilast treatment, 61-78% of patients reported they had achieved these goals; only 12.5% assessed their disease as severe (PtGA, 53.6% at apremilast initiation) and over half reported a DLQI score of 5 or less, indicating improved quality of life. As assessed by the physician, 68.4% and 35.1% of patients achieved at least a 50% and 75% reduction in PASI, respectively, at month 6. Apremilast was well tolerated with no new safety signals identified.
CONCLUSIONS
Our real-world data indicate that apremilast fulfils the expectations of Belgian patients with moderate to severe psoriasis, and from the perspectives of both the patient and physician, apremilast has a positive impact on their disease.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT03097003.
简介
阿普米司特已获批准用于治疗银屑病和银屑病关节炎。然而，关于阿普米司特在临床实践中的疗效和安全性的数据有限。我们从患者和医生的角度评估了在比利时皮肤科医生诊所就诊的中重度斑块状银屑病患者使用阿普米司特的真实世界应用和效果。
方法
本前瞻性观察性研究纳入了 2017 年 4 月 6 日至 2018 年 6 月 30 日期间根据比利时报销标准开始使用阿普米司特治疗的年龄在 18 岁及以上的成年患者。主要结局指标是皮肤病患者受益指数（PBI-S）。次要结局指标包括患者整体评估（PtGA）、皮肤病生活质量指数（DLQI）、银屑病面积和严重程度指数（PASI）和体表面积（BSA）。患者随访时间最长达 18 个月。
结果
总体而言，122 名入组患者接受了至少一剂阿普米司特治疗，其中 89 名患者的治疗时间超过 150 天，被纳入参考人群。在 PBI-S 中，被认为“非常重要”的治疗目标（至少 70%的患者）与身体损伤有关。在接受阿普米司特治疗 6 个月后，61-78%的患者报告达到了这些目标；只有 12.5%的患者评估自己的疾病严重（PtGA，阿普米司特起始时为 53.6%），超过一半的患者报告 DLQI 评分小于等于 5，表明生活质量有所改善。根据医生评估，68.4%和 35.1%的患者在第 6 个月时分别实现了 PASI 至少减少 50%和 75%。阿普米司特耐受性良好，未发现新的安全性信号。
结论
我们的真实世界数据表明，阿普米司特满足了比利时中重度银屑病患者的期望，并且从患者和医生的角度来看，阿普米司特对他们的疾病有积极的影响。
试验注册
ClinicalTrials.gov 标识符 NCT03097003。
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